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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87433

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 22, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

Z-1314-2021
Recall number
Z-1314-2021
Initiated
February 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
102 units total (Domestic: 6 units, Foreign: 86 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Code information

Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

device · product 2 of 3

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Z-1315-2021
Recall number
Z-1315-2021
Initiated
February 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
102 units total (Domestic: 0 units, Foreign: 162 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Code information

Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

device · product 3 of 3

The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Z-1316-2021
Recall number
Z-1316-2021
Initiated
February 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
355 units total (Domestic: 177 units, Foreign: 178 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Code information

Lot: 9557372, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557439, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557440, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557450, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557460, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557444, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557445, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557446, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557453, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557455, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557376, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557377, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557457, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557471, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557473, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557476, Product Code: 150680005, GTIN: 10603295492177 Lot: 9556100. Product Code: 150680006, GTIN: 10603295492184 Lot: 9556127, Product Code: 150680006, GTIN: 10603295492184 Lot: 9556128, Product Code: 150680006, GTIN: 10603295492184 Lot: 9557434, Product Code: 150680007, GTIN: 10603295492191

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

Field note

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